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Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors

NCT01508702 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2016-02-12

Study results available
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Summary

This study will assess the serum uric acid lowering effects and safety of lesinurad compared to placebo in patients who are intolerant or have a contraindication to allopurinol or febuxostat.

Conditions

Interventions

DRUG

lesinurad

Tablets, 400 mg QD

DRUG

Placebo

Tablets, Placebo QD

Sponsors & Collaborators

  • Ardea Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Chris Storgard, MD · Ardea Biosciences, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-10-31
Completion
2013-11-30

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Germany
  • New Zealand
  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01508702 on ClinicalTrials.gov